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Company
•United States

International Medication Systems Ltd., South El Monte, CA – FDA Inspections

Inspection records and compliance data for International Medication Systems Ltd. in South El Monte, California. 17 FDA inspections on record (1 OAI), 5 Form 483s, 1 warning letter, last inspected December 19, 2025.

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Company Profile

This profile covers International Medication Systems Ltd. based in South El Monte, California, United States.

FDA Inspection History

FDA inspections
17
OAI
1
VAI
8
NAI
5
Unclassified
3
Form 483s
5
Warning letters
1

First inspected November 24, 2008. Last inspected December 19, 2025.

Most cited issue areas

  • Procedures for sterile drug products2 inspections
  • Absence of Written Procedures1 inspection
  • Changes to Procedures Not Reviewed, Approved1 inspection

FDA inspections (17)

DateResultFDA center(s)Insp. #
December 19, 2025Not classifiedHuman Drugs · Drug Quality Assurance1296658
October 2, 2024Not classifiedHuman Drugs1232055
February 15, 2023VAIHuman Drugs1199252
May 25, 2022VAIHuman Drugs · Drug Quality Assurance1170352
July 16, 2021NAIHuman Drugs · Drug Quality Assurance1149895
December 20, 2019NAIHuman Drugs · Drug Quality Assurance1116061
March 1, 2019Not classifiedHuman Drugs1083247
February 9, 2017OAIHuman Drugs, Medical Devices & Rad Health · New Drug Evaluation1002629
December 7, 2016NAIHuman Drugs, Medical Devices & Rad Health · Compliance: Devices995548
August 10, 2015VAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance938273
September 12, 2014VAIHuman Drugs · Drug Quality Assurance895290
July 24, 2013NAIHuman Drugs · Drug Quality Assurance841591
June 17, 2013VAIHuman Drugs · Drug Quality Assurance836630
August 31, 2012VAIHuman Drugs · Drug Quality Assurance800638
June 15, 2011NAIHuman Drugs · Drug Quality Assurance731587
August 31, 2009VAIHuman Drugs · Drug Quality Assurance610370
November 24, 2008VAIHuman Drugs · Drug Quality Assurance548110
FDA documents

Form 483s (3)

  • Form 483s · December 19, 2025
  • Form 483s · February 15, 2023
  • Form 483s · May 25, 2022

Warning Letters (1)

  • Warning Letters · December 19, 2025

Other FDA documents (1)

  • Other FDA documents
Other regulators (1)
  • UK MHRA · 1 inspection · last September 6, 2011
People (4)
Gisela Sharp
Person
Nicholas L. Hunt
Person
Khoa Nathan V. Tran
Person
Lisa Shin
Person
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Company Information

Name

International Medication Systems Ltd.

FEI Number

2016148

Address

1886 Santa Anita Ave, South El Monte, California 91733, United States

Country

United States

ID: d323d576-1c13-498f-af78-08d7cc187625

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